| CTRI Number |
CTRI/2025/08/092964 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Aragvadhamrutadi Kashaya vs patoladi kashaya in Amlapitta |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial to Determine Efficacy of Aragvadhamrutadi Kashaya in Management of Amlapitta w.s.r.to Non-Ulcer Dyspepsia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savita Potalaji Kamle |
| Designation |
PG Scholar |
| Affiliation |
SSTs Ayurved Mahavidyalaya,Sangamner |
| Address |
Infront of Prasad hotel,Pune- Nashik highway, Sangamner Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8999718685 |
| Fax |
|
| Email |
kamlesp93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savita Potalaji Kamle |
| Designation |
PG Scholar |
| Affiliation |
SSTs Ayurved Mahavidyalaya ,Sangamner |
| Address |
Infront of Prasad hotel, pune Nashik highway, Sangamner, Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8999718685 |
| Fax |
|
| Email |
kamlesp93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savita Potalaji Kamle |
| Designation |
PG Scholar |
| Affiliation |
SSTs Ayurved Mahavidyalaya Sangamner |
| Address |
Infront of prasad hotel pune Nashik highway sangamner, ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8999718685 |
| Fax |
|
| Email |
kamlesp93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SST Ayurved Mahavidyalaya Sangamner |
| Address |
Front of prasad hotel, pune- nashik highway, Sangamner 422605 dist. Ahmadnagar |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Savita Potalaji kamle |
Department of kayachikitsa,SSTs Ayurved Mahavidyalaya Sangamner Sangamner |
Infront of prasad hotel pune-nashik highway, ghulewadi sangamner 422605
Ahmadnagar
MAHARASHTRA |
8999718685
kamlesp93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aragvadhamrutadi Kashaya |
group A patients given 40ml of Aragvadhamrutadi Kashaya in two divided doses for 4 weeks and results are drawn. |
| Comparator Agent |
Patoladi kwath |
group B patients given 40ml of patoladi kwath in two divided doses for four weeks.Then results are drawn. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 All the patients with sign and symptoms of Amlapitta like Avipak, Klama(Tiredness), Utklesh(Nausea), Tikta-amla Udgar(Bitter-sour belching), Gaurava(Abdominal heaviness), Hrud-Kanth Daha, Aruchi.
2 Patients who are ready to sign inform consent form.
3 patients with age group 18 to 50 years irrespective of sex.
|
|
| ExclusionCriteria |
| Details |
1 Known case of bleeding disorders, CA stomach patients.
2 Known case of severe systemic disorder and endocrine disorder like DM, Thyroid disorder patients.
3 Lactating and pregnant women.
4. Known case of TB, HIV, Hiatus-hernia, achalasia cardia.
5. Known case of Helicobacter Pylori infection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Randomized controlled clinical trial to determine efficacy of
Aragvadhamrutadi Kashaya in management of Amlapitta w.s.r. to Non-
Ulcer Dyspepsia. |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief of amlapitta symptoms |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
it is randomized controlled clinical trial to determine efficacy of Aragvadhamrutadi Kashaya in management of Amlapitta w.s.r. to Non-Ulcer Dyspepsia with age group 18-50 years both in male and females included 40 patients in each trial and control group. |